Defining Disease Progression and Drug Durability in Type 2 Diabetes Mellitus

Abstract This communication shares insights into the definition of disease progression and drug durability in type 2 diabetes. Disease progression may be defined as gradual worsening of beta-cell function, clinically observed as an increase in drug dosage, drug frequency or number of glucose lowering drugs needed to maintain HbA1c control; and/or a ≥0.5% rise in HbA1c, unexplained by acute, modifiable factors, while using the same drug regimen; and/or as the occurrence or worsening of cardiovascular or microvascular complications, in spite of standard care, over a pre-specified time period. Durability of a drug or a drug combination may be defined as its ability to postpone or delay progression of disease, in a safe and well tolerated manner. Thus, all drugs that are able to prevent disease progression (i.e., postpone loss of glycaemic control, need for intensification of therapy or onset or worsening of complications) may be termed ‘durable’.